WO2018096549A1 - Cathéter intraveineux avec mécanisme d'auto-activation pour empêcher un reflux du sang - Google Patents

Cathéter intraveineux avec mécanisme d'auto-activation pour empêcher un reflux du sang Download PDF

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Publication number
WO2018096549A1
WO2018096549A1 PCT/IN2016/050418 IN2016050418W WO2018096549A1 WO 2018096549 A1 WO2018096549 A1 WO 2018096549A1 IN 2016050418 W IN2016050418 W IN 2016050418W WO 2018096549 A1 WO2018096549 A1 WO 2018096549A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
needle
actuator
hub
recess
Prior art date
Application number
PCT/IN2016/050418
Other languages
English (en)
Inventor
Neeraj Gupta
Original Assignee
Neeraj Gupta
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Neeraj Gupta filed Critical Neeraj Gupta
Priority to PCT/IN2016/050418 priority Critical patent/WO2018096549A1/fr
Publication of WO2018096549A1 publication Critical patent/WO2018096549A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0693—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof including means for seal penetration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0693—Flashback chambers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle

Definitions

  • the present invention relates to a catheter device having self-activating mechanism.
  • the self-activating catheter assembly comprises, a catheter hub (1), cylindrical valve (2), actuator (3), needle (13) and a flash back chamber (18).
  • the intravenous catheter of present invention having a novel one way valve design which prevent of reverse flow of blood.
  • Intravenous catheters have also been in existence since many years. Intravenous catheters are venous devices used to infuse medication or fluids directly into a vein or draw blood samples for testing. Intravenous catheters are introduced into vein using a needle and fixed to the patient's skin with an adhesive tape.
  • a closed system intravenous catheter is used in which the flow of blood is stopped by having a dead stopper in the path of the blood flow and a side port is provided at an angle to the catheter in order allow air escape for flashback visualization and to allow infusion of fluid.
  • dead stopper in the path of the blood flow
  • side port is provided at an angle to the catheter in order allow air escape for flashback visualization and to allow infusion of fluid.
  • the catheter space may be blocked by a mandrel or obturator which requires proper skill and training and that further makes the product complicated and expensive.
  • US Patent 4874377 describes a catheter hub assembly with a valve to prevent the back flow of blood.
  • the valve deforms with pressure when a connector is attached to the catheter hub and the deformation is controlled in a way that allows fluid to pass. It is assumed that in order to allow for the deformation the diameter and overall size of the hub would be increased. Though a practically possible solution, the increase in size interferes substantially with the overall functioning of the product and greatly impacts patient comfort.
  • US patent 5064416 describes a frustoconical actuator with a smooth tip that is activated with a luer connection but slips back when the connection is removed. This type of movement is fraught with practical problems especially for devices where the shelf life is long (e.g. 3 years or more). Further the patent does not describe how the valve may be designed or fitted into the catheter hub.
  • US patent 5154703 describes a simple disc shaped valve combined with a sharp needle that pierces this disc on connection with a luer.
  • the addition of a sharp needle brings many safety-related issues including proper handling and disposal of the product.
  • Assembling a sharp needle of a small size within a small assembly is also complicated.
  • US Patent 5053014 describes a 2-part catheter hub assembly into which a membrane is inserted using an interference fit. A smooth plunger is then also enclosed within the 2 part assembly so that it penetrates the membrane when a luer connection is applied.
  • the present invention provides an improved and easy to use solution by designing a catheter with one way valve which effectively block the reverse flow of blood and prevents blood spillage.
  • the main object of present invention is to provide an intravenous catheter to avoid reverse flow of blood.
  • Another object of present invention is to provide an intravenous catheter with a novel one way valve design which is responsible for prevention of reverse flow of blood.
  • Another object of present invention is to provide a mechanism for preventing reverse flow of blood that may be applied to a variety of other devices
  • the main aspect of present invention is to provide a catheter device having self- activating mechanism comprising;
  • a catheter hub (1) having a proximal end and a distal end, the catheter hub including a substantially co-axial recess with an undercut towards proximal end that allows a one way cylindrical valve (2) made of flexible material to be held in place towards proximal end in the recess (10) with first end of the cylindrical valve abutting the undercut (7) and the second end abutting against reduced diameter (8) within the recess (10) in the catheter hub towards distal end; the first end of valve being open and the second end of valve being closed, having a slit (9) on the second end;
  • the cylindrical valve having a co-axial recess, the recess having a ring protruding on inner surface towards distal end;
  • a tubular actuator (3) having a closed end and an open end; the actuator having a cylindrical outer surface with a circular depression (12) towards distal end, the actuator arranged within the recess of the cylindrical valve with the protruding ring (11) within the recess of the cylindrical valve mating with the circular depression (12) of the actuator ;
  • the slit on the closed end of the cylindrical valve is configured to open when the needle pierces the slit and to self- seal the closed end when the needle is withdrawn.
  • the catheter hub (1) is made of a rigid biocompatible plastic.
  • the actuator (3) is made of a rigid plastic material or metal.
  • Another embodiment of the present invention is the distal end of actuator is rounded and smooth to allow for piercing of the slit (9) of the cylindrical valve (2).
  • Another embodiment of the present invention is the flexible material used in making the cylindrical valve is selected from the group consisting of silicone, rubber etc.
  • the actuator (3) is configured to move along the axis of the catheter hub when a force is applied to it.
  • the slit (9) may be of any shape preferably Y-shaped slit or X-shaped slit.
  • the actuator (3) is configured to move along axis of catheter hub upon inserting a luer connector in to the catheter hub at universal 6% taper (6).
  • Another embodiment of the present invention is a luer cap (23) is provided to seal proximal 6% taper of the catheter hub (6).
  • Another embodiment of the present invention is the actuator (3) comprises a hole (15) of sufficient diameter towards distal end to allow requisite flow through the catheter.
  • Another embodiment of the present invention is the actuator (3) comprises wall of low thickness.
  • flashback chamber (18) either have a porous filter (19) or a cover (20) that allows air to escape and blood to flow inside the flash back chamber (18)
  • the flashback chamber (18) either have a porous filter (19) or a cover (20) that allows air to escape and blood to flow inside the flash back chamber (18)
  • the distal part of the needle is partially encased by a needle cover assembly removably connected to the catheter hub, wherein the needle cover assembly comprises:
  • a needle cover having a safety element with a blocking hole preventing the passing through of the distal part of the needle, the needle cover being connected to the catheter hub by a lock and jaws and by engaging a needle cover hole with a projection on the catheter hub ,
  • a needle hub having a through hole in which the needle is press fitted, the needle hub being connected to the flashback chamber through an extended portion, and
  • a casing enclosing both the needle cover and the needle hub, the casing being connected to the needle cover via projections and to the needle hub by engaging flanges and hooks in slots provided on the needle hub.
  • Another embodiment of the present invention is that the assembly of preventing back flow to the catheter may be assembled or conjoined with any type of IV Cannula either conventional or with an anti-needle stick safety device or any other additional feature.
  • Fig.l shows diagrammatic view of the catheter hub, valve, valve actuator, catheter holder and catheter
  • Fig.2A-2D shows diagrammatic view of the valve
  • Fig.3A-3D shows diagrammatic view of the valve actuator
  • Fig.4-6 shows diagrammatic view of various types of standard catheters that may incorporate the valve and actuator
  • Fig.7-9 shows diagrammatic view of various types of catheters that may incorporate the valve and actuator, along with incorporating an anti-needle stick safety mechanism
  • the present invention discloses a catheter device which avoids back flow of blood from one way valve or vein.
  • the catheter comprises of catheter hub, one way valve mechanism, needle hub and flashback chamber.
  • the catheter hub is made up of biocompatible material which is rigid in nature which holds the one way valve securely and the position of the valve is fixed along the axis of the catheter hub.
  • the one way valve is cylindrical in shape, with a slit or groove in at the downstream end and a hollow recess at the upstream end.
  • the slit is formed in a way that it prevents flow of blood from the downstream end.
  • the hollow recess holds in place a hollow actuator that can slide along the length of the cylindrical valve.
  • Flash chamber is a portion of catheter where blood is collected and provides a visual inspection of bold collected.
  • a needle assembly and needle hub is inserted into catheter hub through the valve and a flashback chamber.
  • the catheter hub 1 consists of a distal end where a catheter 4 is attached.
  • the catheter may be attached to the hub with the help of a catheter holder 5.
  • the proximal end of the catheter hub is shaped to provide a universal 6% taper 6.
  • the catheter hub 1 consists of an undercut 7 that allows for the cylindrical valve 2 to be held in place at the proximal end, while the distal end of the cylindrical valve butts against a reduced diameter 8 within the catheter hub.
  • the distal end of the cylindrical valve is a flat disc, and has slits 9.
  • Proximal to the disc is a recess 10 that also consists of a ring 11 that is an integral part of the valve. This recess houses the actuator 3.
  • the shape and size of the ring 11 is designed to mate with a circular depression 12 in the actuator so that it is held in place and does not move unless a force is applied to it.
  • the location of the actuator 3 is such that it moves along the axis of the catheter hub as and when a luer connector is inserted into the catheter hub, at the universal 6% taper 6. As the actuator moves, it pierces the slits 9 of the valve and thereby allows for fluid to flow through the catheter body and into the catheter 4.
  • the entire assembly is designed in a way that a needle 13 may pass through and through the assembly. The needle will pierce the valve through the slits 9. When the device is inserted into the vein, blood would flow through the needle 13 and into the flashback chamber 18 thereby confirming venipuncture.
  • the valve 2 is made of usually silicone, rubber etc, such that the slits would self-seal when the needle is withdrawn and thereby prevent the flow of blood back through the valve and out of the catheter hub.
  • FIG. 2 shows an enlarged diagrammatic view of the valve 2, with the various elements as described above such as the slits 9, the hollow part 10 and the internal ring 11.
  • the slits 9 may be of any suitable shape, such as Y-shaped slit, an X-shaped slit, T-shaped slit, L-shaped, N-shaped, C-shaped, G-shaped, H-shaped etc. This silt will self seal once the needle is withdrawn and thereby prevent the flow of blood back through the valve and out of the catheter hub.
  • the actuator is displayed infigure 3.
  • the actuator is hollow and with narrow wall 14.
  • the actuator is having the circular depression 12.
  • the circular depression 12 helps in holding the actuator in the cylinderical ring when it is in mating position with the circular ring 11.
  • the distal end of the actuator 16 is rounded and smooth in order to allow for easy piercing of the valve, and it has a hole 15 of sufficient diameter to allow the requisite flow through the catheter.
  • the diameter of the hole 15 may be altered according to the diameter of the catheter 4 in order to provide less or more flow as required in the device.
  • FIG. 4 shows various models of intravenous catheters into which the proposed invention may be integrated.
  • the intravenous catheter would have the basic elements such as the catheter 4, the needle 13, and the catheter hub 1 along with the needle hub 17, the flashback chamber 18.
  • the flashback chamber would have either a porous filter 19 or a cover 20 that allows air to escape and blood to flow into the flashback chamber 18.
  • the catheter hub 1 may be of different designs and may or may not incorporate wings 21 or an additional injection port 22.
  • a Luer cap 23 may also be provided to seal the proximal 6% luer 6 of the catheter hub 1 when the catheter is not in use. This luer cap and any other luer connection may be pressed into the 6% taper 6 or in case such a cap has threads it may be screwed on to the catheter hub 1 with the help of the flanges 25 available on the catheter hub.
  • An anti-needle stick safety mechanism may be easily incorporated with the catheter assembly without interfering with the functioning of the proposed invention.
  • Figure 5 shows some examples of such catheters where both the proposed invention and anti- needle stick mechanism are integrated.
  • the anti-needle stick mechanism 24 is proximal to the sub-assembly of the proposed invention and therefore does not affect the functioning of the proposed invention.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif cathéter ayant un mécanisme d'auto-activation. L'ensemble cathéter à auto-activation comprend, une embase de cathéter (1), une valve cylindrique (2), un actionneur (3), une aiguille (13) et une chambre arrière transparente (18). Le cathéter intraveineux de la présente invention ayant une nouvelle conception de valve unidirectionnelle qui empêche un écoulement inverse (un reflux) de sang.
PCT/IN2016/050418 2016-11-23 2016-11-23 Cathéter intraveineux avec mécanisme d'auto-activation pour empêcher un reflux du sang WO2018096549A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IN2016/050418 WO2018096549A1 (fr) 2016-11-23 2016-11-23 Cathéter intraveineux avec mécanisme d'auto-activation pour empêcher un reflux du sang

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IN2016/050418 WO2018096549A1 (fr) 2016-11-23 2016-11-23 Cathéter intraveineux avec mécanisme d'auto-activation pour empêcher un reflux du sang

Publications (1)

Publication Number Publication Date
WO2018096549A1 true WO2018096549A1 (fr) 2018-05-31

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021048867A1 (fr) 2019-09-10 2021-03-18 Neeraj Gupta Dispositif de cathéter intraveineux

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020128604A1 (en) * 2001-03-12 2002-09-12 Hiroaki Nakajima Indwelling catheter
US20060264834A1 (en) * 2005-05-20 2006-11-23 Vaillancourt Michael J Valve for introducer needle
US20130165868A1 (en) * 2011-10-06 2013-06-27 Becton, Dickinson And Company Multiple use stretching and non-penetrating blood control valves
US20140046258A1 (en) * 2009-02-11 2014-02-13 Becton, Dickinson And Company Systems and methods for providing a flushable catheter assembly
WO2016063287A1 (fr) * 2014-10-22 2016-04-28 Neeraj Gupta Cathéter intraveineux (iv) comprenant un mécanisme de sécurité anti-piqûre d'aiguille

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020128604A1 (en) * 2001-03-12 2002-09-12 Hiroaki Nakajima Indwelling catheter
US20060264834A1 (en) * 2005-05-20 2006-11-23 Vaillancourt Michael J Valve for introducer needle
US20140046258A1 (en) * 2009-02-11 2014-02-13 Becton, Dickinson And Company Systems and methods for providing a flushable catheter assembly
US20130165868A1 (en) * 2011-10-06 2013-06-27 Becton, Dickinson And Company Multiple use stretching and non-penetrating blood control valves
WO2016063287A1 (fr) * 2014-10-22 2016-04-28 Neeraj Gupta Cathéter intraveineux (iv) comprenant un mécanisme de sécurité anti-piqûre d'aiguille

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021048867A1 (fr) 2019-09-10 2021-03-18 Neeraj Gupta Dispositif de cathéter intraveineux
CN115003360A (zh) * 2019-09-10 2022-09-02 迈德资源国际有限责任公司 静脉内导管装置
JP2022551563A (ja) * 2019-09-10 2022-12-12 グプタ，ネーラジ 静脈内カテーテルデバイス
EP4028104A4 (fr) * 2019-09-10 2023-12-13 MedSource International LLC Dispositif de cathéter intraveineux
JP7424680B2 (ja) 2019-09-10 2024-01-30 メドソース・インターナショナル・リミテッド・ライアビリティ・カンパニー 静脈内カテーテルデバイス
US12017011B2 (en) 2019-09-10 2024-06-25 Medsource International Llc Intravenous catheter device
JP7566382B2 (ja) 2019-09-10 2024-10-15 メドソース・インターナショナル・リミテッド・ライアビリティ・カンパニー 静脈内カテーテルデバイス

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